methotrexate (oral)

What is the most important information I should know about methotrexate?

You must use the correct dose of methotrexate for your condition. Methotrexate is usually taken once or twice per week and not every day. Follow the directions on your prescription label. Some people have died after taking methotrexate every day by accident. Ask your doctor if you have any questions about your dose of methotrexate or how often to take it.

Methotrexate can cause serious or life-threatening side effects on your liver, lungs, kidneys, and bone marrow (immune system). Do not take this medication in larger amounts, or take it for longer than prescribed. Follow the directions on your prescription label.

Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you have liver disease (especially if caused by alcoholism), a blood cell or bone marrow disorder, or if you are breast-feeding a baby.

This medication can cause birth defects in an unborn baby. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you are pregnant. Use an effective form of birth control, whether you are a man or a woman. Tell your doctor if you or your sexual partner become pregnant during treatment.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

There are many other medicines that can interact with methotrexate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What is methotrexate?

Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat certain types of cancer of the breast, skin, head and neck, or lung. Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis.

Methotrexate is usually given after other medications have been tried without successful treatment of symptoms.

Methotrexate may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking methotrexate?

Do not use this medication if you are allergic to methotrexate. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you have:

• liver disease;
• alcoholism or cirrhosis of the liver;
• a blood cell disorder such as anemia (lack of red blood cells) or leukopenia (lack of white blood cells);
• a bone marrow disorder; or
• if you are breast-feeding a baby.

Methotrexate is sometimes used to treat cancer even when patients do have one of the conditions listed above. Your doctor will decide if this treatment is right for you.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take methotrexate:

• kidney disease;
• liver disease;
• lung disease or pneumonia;
• stomach ulcers;
• any type of infection; or
• if you are receiving radiation treatments.

FDA pregnancy category X. Methotrexate can cause birth defects in an unborn baby. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Use birth control to prevent pregnancy while you are using methotrexate, whether you are a man or a woman. Methotrexate use by either parent may cause birth defects.

Before you start taking methotrexate, your doctor may want you to have a pregnancy test to make sure you are not pregnant.

If you are a man, use a condom to keep from causing a pregnancy while you are using methotrexate. Continue using condoms for at least 90 days after your treatment ends.

If you are a woman, use an effective form of birth control while you are taking methotrexate, and for at least one cycle of ovulation after your treatment ends.

Do not give this medicine to a child without the advice of a doctor.

Older adults may be more likely to have side effects from this medication.

How should I take methotrexate?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

You must use the correct dose of methotrexate for your condition. Methotrexate is usually taken once or twice per week and not every day. Follow the directions on your prescription label. Some people have died after taking methotrexate every day by accident. Ask your doctor if you have any questions about your dose of methotrexate or how often to take it.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

It is important to use methotrexate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested, and you may need an occasional liver biopsy. Do not miss any scheduled appointments.

Store methotrexate at room temperature away from moisture and heat.

What happens if I miss a dose?

Call your doctor if you miss a dose of methotrexate.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of methotrexate can be fatal.

Overdose symptoms may include pale skin, easy bruising or bleeding, unusual weakness, mouth sores, nausea, vomiting, black or bloody stools, coughing up blood or vomit that looks like coffee grounds, and urinating less than usual or not at all.

What should I avoid while taking methotrexate?

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds), especially if you are being treated for psoriasis. Methotrexate can make your skin more sensitive to sunlight and your psoriasis may worsen.

Avoid drinking alcohol while taking methotrexate.

What are the possible side effects of methotrexate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using methotrexate and call your doctor at once if you have any of these serious side effects:

• dry cough, shortness of breath;
• diarrhea, vomiting, white patches or sores inside your mouth or on your lips;
• blood in your urine or stools;
• urinating less than usual or not at all;
• fever, chills, body aches, flu symptoms;
• sore throat and headache with a severe blistering, peeling, and red skin rash;
• pale skin, easy bruising or bleeding, weakness; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• nausea, vomiting, upset stomach;
• dizziness, tired feeling;
• headache;
• bleeding of your gums; or
• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect methotrexate?

Before taking methotrexate, tell your doctor if you are using any of the following drugs:

• azathioprine (Imuran);
• chloramphenicol (Chloromycetin);
• hydroxychloroquine (Plaquenil, Quineprox);
• retinol, tretinoin (Retin-A), isotretinoin (Accutane);
• steroids (prednisone and others);
• sulfa drugs such as Azulfidine, Bactrim, or Septra;
• phenytoin (Dilantin);
• probenecid (Benemid);
• tetracycline (Brodspec, Panmycin, Sumycin, Tetracap);
• theophylline (Elixophyllin, Slo-Bid, Theobid, Theo-Dur);
• gold treatments such as auranofin (Ridura);
• oral diabetes medications such as acetohexamide (Dymelor), chlorpropamide (Diabinese), glipizide (Glucotrol), glimepiride (Amaryl), or tolbutamide (Orinase);
• a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen), and others;
• medicines that reduce stomach acid, such as esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), or rabeprazole (Aciphex);
• NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), naproxen (Aleve, Naprosyn), meloxicam (Mobic), piroxicam (Feldene), and others; or
• salicylates such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others.

This list is not complete and there may be other drugs that can interact with methotrexate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about methotrexate.